POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)

• K Number: K023262
• Device Name: POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
• Manufacturer: PERUSAHAAN GETAH ASAS SDN BHD
• Date Cleared: 2002-10-28 ( 28 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder-Free, Latex Patient Examination Glove With Protein Labeling Claim. (contain 200 microgram or less of total water extractable protein per gram glove).

AI/ML Overview

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a "Powder-Free, Latex Patient Examination Glove with Protein Labeling Claim."

The text focuses on:

• The FDA's determination of substantial equivalence to a legally marketed predicate device.
• Regulatory classifications and requirements for general controls (registration, labeling, good manufacturing practice).
• Contact information for various FDA offices.
• The intended use of the device.

There is no information within the provided text about:

1. Specific acceptance criteria for device performance.
2. Details of any study conducted to demonstrate the device meets performance criteria (such as sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance).
3. Reported device performance metrics.

The document states a "Protein Labeling Claim: Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Glove," which is a characteristic of the device, but it does not present this as an "acceptance criterion" in the context of a performance study with reported results. The 510(k) process primarily assesses substantial equivalence to a predicate device, rather than requiring extensive de novo clinical performance studies for low-risk devices like gloves.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.